TEST MATERIAL 500 mg of the test item was first applied to a gauze patch, which was then carefully applied to the skin with good contact and uniform distribution of the test item on the skin. In order to ensure good contact with the skin, it was moistened with the smallest amount of aqua ad injectionem.The vehicle was chosen due to its non-irritating characteristics.

TEST SITE 500 mg of the moistened test item was applied at a single dose to a small area (approximately 6 cm²) of skin on one side of the dorsal area and covered with a gauze patch, which was held in place with a non-irritating tape. The untreated other side served as control. The test item was applied to the patch first, moistened with the smallest amount of aqua ad injectionem and then applied to the skin. The patch was fixed with a semi-occlusive dressing. The untreated other side served as control. The limits of the application site were marked with an ink marker. Access by the animal to the patch and ingestion or inhalation of the test chemical were prevented.

INITIAL AND CONFIRMATORY TESTINGAs there was no information about the skin irritation/ corrosion potential of the test item, a single animal test was employed. Up to three test patches were applied sequentially to the animal. The first patch was removed after three minutes. No serious skin reaction was observed, so a second patch was applied at a different site and removed after one hour. The observations at this stage indicated that exposure can humanely be allowed to extend to four hours, so a third patch was applied and removed after four hours, and the response was graded. No corrosive effect was observed after the last patch was removed, so the animal was further observed.The results of the initial test indicated that the test item is not corrosive to the skin using the procedure described. In order to confirm the response, two additional animals were treated in the same manner.

REMOVAL OF TEST SUBSTANCEAt the end of the exposure period, sterile water was used to remove residual test item from animal #1. Thereafter, as the test item showed a water-repellent effect, an appropriate solvent, cottonseed oil was used for rinsing the application site in animal #1. For animal #2 and #3 solely cottonseed oil was used to remove test item residues immediately after patch removal. The solvent was chosen in order not to alter the existing response or the integrity of the epidermis.

FURTHER OBSERVATIONS- body weights: prior to the administration and at the end of the observation period- local effects such as hyperplasia, scaling, discolouration, fissures and scabs - systemic effects

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

ANIMAL #1:After patch removal during and immediately after sequential application (3 min, 1 hour, 4 hours) signs of irritation were noted in animal #1 (erythema grade 1 immediately after the 1-hour and the 4-hour exposure periods). 1 hour later no signs of irritation were observed. Slight irritation was noted from 24 hours until 5 days after exposure and was fully reversible within 6 days after patch removal. The mean erythema score of animal #1, following grading at 24, 48 and 72 hours post-application, was calculated to be 1.00.

ANIMAL #2:Animal #2 started showing erythema grade 1 at 24 hours after patch removal. This slight sign of irritation persisted until study end, 14 days after application. The mean erythema score of animal #2, following grading at 24, 48 and 72 hours after installation of the test material, was calculated to be 1.00.

ANIMAL #3:Animal #3 showed erythema grade 1 at 1 hour after patch removal. Irritation score increased to erythema grade 2 24 hours after exposure and decreased again to grade 1 2 days later. By 7 days after application signs of irritation were fully reversible. The mean erythema score of animal #3, following grading at 24, 48 and 72 hours after installation of the test material, was calculated to be 2.00.

Other effects:

- No adverse changes apart from irritant/corrosive response data were observed at the skin sites. However,- Test item residues were detected at the application sites in all animals almost throughout the whole observation period.- Neither mortalities nor significant clinical signs of toxicity were observed. - The body weight development was within the expected range.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not irritating to the skin.According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin corrosion/irritation:

The OECD 439 (GLP) test method was was not applicable, due to the physical form of the substance (highly viscous and sticky).

The OECD 435 test method was not applicable, since the receptor fluid was not activated by the test substance. Thus, an in vivo skin irritation study (OECD 404; GLP) was conducted. In this study, the substance displayed no irritating properties to the skin.

Eye irritation:

The OECD 437 (GLP) test method was was not applicable, due to the physical form of the substance (highly viscous and sticky).

Thus, an in vivo follow-up test (OECD 405; GLP) was foreseen, but were not performed, since pre-tests indicated that testing is technically not feasible.

Justification for classification or non-classification

Skin irritation:

Fatty acids, tall-oil, manganese salts does not possess a skin irritating potential based on an in vivo OECD 404 test and does not require classification according to Regulation (EC) No 1272/2008 and its subsequent adaptations

Eye irritation:

No hazard conclusion can be drawn with regard to local effects to the eyes, since the substance cannot be applied in in vitro or in vivo eye irritation test systems due to the physical form.

Fatty acids, tall-oil, manganese salts is not classified for eye irritating effects because of lacking data.

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

Route: .live2

Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.

Do not show this message again

This website uses cookies to ensure you get the best experience on our websites.